The context of the US is marked by a higher freedom in establishing pharmaceutical prices what, together with the existence of some of the biggest pharma companies, continues placing the US as one of the biggest shareholders of the market. Hence, the interest in commercializing in the US is notorious for those clients wishing to boost their possibilities.
Nonetheless, the US counts with a rigid regulatory system headed by the FDA, together with CDER and CBER and the Code of Federal Regulations, among others. For a market strategy to be successful within the US context, a good and detailed understanding on how processes and standards vary, as well as having presence and contact with the regulatory authorities becomes paramount when looking for an expansion from the European market.
Our experience in the US aims at positioning your product in a valuable place to foster approval and commercialization.
The context of the US is marked by a higher freedom in establishing pharmaceutical prices what, together with the existence of some of the biggest pharma companies, continues placing the US as one of the biggest shareholders of the market. Hence, the interest in commercializing in the US is notorious for those clients wishing to boost their possibilities.
Nonetheless, the US counts with a rigid regulatory system headed by the FDA, together with CDER and CBER and the Code of Federal Regulations, among others. For a market strategy to be successful within the US context, a good and detailed understanding on how processes and standards vary, as well as having presence and contact with the regulatory authorities becomes paramount when looking for an expansion from the European market.
Our experience in the US aims at positioning your product in a valuable place to foster approval and commercialization.
USA Solutions
Schedule a free meeting!
Discuss your case with our experts and receive a valuable feedback
Share
Why Asphalion?
Asphalion has been working in Regulatory activities with the FDA since 2005 and has established a strategic alliance with Reguliance, a company founded by Bruce Thompson specialized in providing regulatory support and project management to drug and biotech firms.
For the last 3 years, ASPHALION has managed over 70 projects involving the preparation, submission and/or maintenance of different types of applications for US, including Pre-IND meetings, INDs, NDAs, BLAs, ANDAs, DMFs, ODD and PSPs, in direct contact with the FDA.
Main benefits
Services
© Asphalion
Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts.
We will be happy to assist you!
Cookie | Duration | Description |
---|---|---|
__cfruid | session | Cloudflare sets this cookie to identify trusted web traffic. |
cookielawinfo-checkbox-advertisement | session | Set by the GDPR Cookie Consent plugin, this cookie is used to record the user consent for the cookies in the "Advertisement" category . |
cookielawinfo-checkbox-analytics | 11 months | This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics". |
cookielawinfo-checkbox-functional | 11 months | The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional". |
cookielawinfo-checkbox-necessary | 11 months | This cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary". |
cookielawinfo-checkbox-others | 11 months | This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other. |
cookielawinfo-checkbox-performance | 11 months | This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance". |
elementor | never | This cookie is used by the website's WordPress theme. It allows the website owner to implement or change the website's content in real-time. |
viewed_cookie_policy | 11 months | The cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data. |
Cookie | Duration | Description |
---|---|---|
_ga | 2 years | The _ga cookie, installed by Google Analytics, calculates visitor, session and campaign data and also keeps track of site usage for the site's analytics report. The cookie stores information anonymously and assigns a randomly generated number to recognize unique visitors. |
_gat_gtag_UA_46600265_1 | 1 minute | Set by Google to distinguish users. |
_gid | 1 day | Installed by Google Analytics, _gid cookie stores information on how visitors use a website, while also creating an analytics report of the website's performance. Some of the data that are collected include the number of visitors, their source, and the pages they visit anonymously. |
CONSENT | 2 years | YouTube sets this cookie via embedded youtube-videos and registers anonymous statistical data. |
Cookie | Duration | Description |
---|---|---|
VISITOR_INFO1_LIVE | 5 months 27 days | A cookie set by YouTube to measure bandwidth that determines whether the user gets the new or old player interface. |
YSC | session | YSC cookie is set by Youtube and is used to track the views of embedded videos on Youtube pages. |
yt-remote-connected-devices | never | YouTube sets this cookie to store the video preferences of the user using embedded YouTube video. |
yt-remote-device-id | never | YouTube sets this cookie to store the video preferences of the user using embedded YouTube video. |
yt.innertube::nextId | never | This cookie, set by YouTube, registers a unique ID to store data on what videos from YouTube the user has seen. |
yt.innertube::requests | never | This cookie, set by YouTube, registers a unique ID to store data on what videos from YouTube the user has seen. |
Cookie | Duration | Description |
---|---|---|
countryID | 1 month | No description |
langID | 1 month | No description |